Cleared Traditional

K964190 - ERA 300 DUAL CHAMBER PACING SYSTEM ANAL...

K964190 is the FDA 510(k) clearance for ERA 300 DUAL CHAMBER PACING SYSTEM ANAL... by Biotronik, Inc.. It is a Class 2 Cardiovascular device (product code DTE) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K964190 · Biotronik, Inc. · Cardiovascular device
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Jul 1997
Decision
262d
Days
Class 2
Risk

K964190 is an FDA 510(k) clearance for the ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on July 10, 1997 after a review of 262 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K964190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1996
Decision Date July 10, 1997
Days to Decision 262 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 125d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTE Pulse-generator, Pacemaker, External

All 25
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K964190.
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924 · Medtronic, Inc. · Oct 2013
ERA 3000 PACING SYSTEM ANALYZER
K042708 · Biotronik, Inc. · Oct 2004
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
K971474 · Medtronic Vascular · Jul 1997
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · Medtronic Vascular · Feb 1991
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
K893633 · Medtronic Vascular · Jun 1989
ERA-20
K853194 · Biotronik Sales, Inc. · Mar 1987